BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7572384 · Received June 6, 2018

    Report

    Report Number
    3009185973-2018-00167
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 24, 2018
    Report Date
    February 24, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT IQ-VIEW SOFTWARE WAS NOT FUNCTIONNING ON THE COMPUTER FOR PRE-OP PLANNING. A REVIEW OF THE DHR INDICATED THAT THIS COMPUTER CONFIGURATION HAS BEEN CHANGED MULTIPLE TIMES. DURING THE LAST UPDATE, THE GLOBAL SOFTWARE VERSION WAS UPDATED, BUT NOT THE IQ-VIEW VERSION, WHICH CAUSED A COMPATIBILITY ISSUE AND THEREFORE THE REPORTED ISSUE. THIS CONFIGURATION ERROR IS DUE TO AN INCORRECT COMPUTER FOR PRE-OP PLANNING REWORK PROCESS USED.(B)(4).

    Description of Event or Problem · 0

    DURING A VISIT OF MEDTECH FIELD SERVICE ENGINEER, THE SURGEON REPORTED THAT THE IQ-VIEW WAS NOT FUNCTIONING ON THE COMPUTER FOR PRE-OPERATIVE PLANNING. HE STATED THAT HE RECEIVED AN ERROR MESSAGE WHEN TRYING TO LOAD PATIENT DATA FROM PACS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K151359/K172444.

    Description of Event or Problem · 1

    DURING A VISIT OF MEDTECH FIELD SERVICE ENGINEER, THE SURGEON REPORTED THAT THE IQ-VIEW WAS NOT FUNCTIONING ON THE COMPUTER FOR PRE-OPERATIVE PLANNING. HE STATED THAT HE RECEIVED AN ERROR MESSAGE WHEN TRYING TO LOAD PATIENT DATA FROM PACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417361 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA COMPUTER FOR PRE-OP PLANNING 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1